US Pharm. 2013;38(1):7.
Silver Spring, MD—The FDA has approved Iclusig (ponatinib) to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ ALL), two rare blood and bone marrow diseases. The drug was approved more than 3 months before the FDA was scheduled to complete its review of the drug application. Iclusig, which blocks certain proteins that promote the development of cancerous cells, is used to treat patients with CML or Ph+ ALL that is resistant or intolerant to tyrosine kinase inhibitors. The drug carries a black box warning noting the occurrence of blood clots and liver toxicity. Some of the more common side effects in clinical trials were high blood pressure, abdominal pain, and rash.
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